FFP Usage in Pediatric CV Surgery

University of Alberta

Status: Completed

Conditions: Coagulopathy; Congenital Heart Disease

Study type: Observational

Funder types: Other

Identifiers

NCT05819788

Pro00129275

Details and patient eligibility

About

When small children undergo heart surgery with the heart-lung machine, in the past, blood products to help the blood clot such as Fresh Frozen Plasma (FFP) was routinely used in children under 10kg. With blood clot monitoring technology, we feel that it might not be necessary to expose all children to FFP. We want to determine if those children who did not receive FFP bleed more or require more blood products as compared to those who did receive FFP while on the heart lung machine.

Full description

This will be a single center, retrospective study. Our cohort will include pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass between January 2019 and January 2023. Patients will be divided into two groups: FFP given at onset of CPB and no FFP given intraoperatively. Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded. Patient clinical, surgical, and bypass characteristics, transfusion, and bleeding outcomes will be collected using REDCAP and via chart review using Connect Care.

Enrollment: 431 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• pediatric patients between 4 and 8 kilograms undergoing congenital cardiac surgery with cardiopulmonary bypass

Exclusion criteria

• Patients requiring FFP for heparin resistance and anti-thrombin III deficiency will be excluded

Trial design

431 participants in 2 patient groups

FFP

Description:

Patients undergoing CPB receiving FFP

no FFP

Description:

Patients undergoing CPB not receiving FFP